Allergan and Hungarian drugmaker Gedeon Richter have announced positive results from a Phase III trial of cariprazine in bipolar depression.
The companies now have positive results from three pivotal clinical trials of cariprazine as a treatment for adults with major depressive episodes associated with bipolar I disorder.
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In the study, 493 patients were given cariprazine 1.5mg, cariprazine 3mg or placebo to evaluate the efficacy, safety and tolerability of the drug in patients with bipolar I depression. The drug met the primary endpoint of a significantly greater improvement than placebo according to the Montgomery-Asberg Depression Rating Scale.
This follows positive Phase II topline results published in December 2017.
The companies plan to submit a Supplemental New Drug Application to the US Food and Drugs Administration (FDA) in the second half of 2018.
Harvard Medical School associate clinical professor of psychiatry Dr Gary Sachs said: “Treating bipolar depression can be very difficult given the few therapies available to manage these symptoms of bipolar I disorder. Further, there are a limited number of products available to help treat the full range of bipolar disorder, from mania through depression.
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By GlobalData“This data is encouraging for patients and the broader psychiatry community, as it demonstrates cariprazine’s potential in treating the full spectrum of the disorder.”
Cariprazine is currently approved in the US under the brand name Vraylar for the treatment of schizophrenia in adults, and the treatment of manic or mixed episodes associated with bipolar I disorder in adults.
Vraylar, an oral, once-daily atypical antipsychotic, was discovered and co-developed by Gedeon Richter and is licensed by Allergan in the US and Canada. For more than a decade both companies have conducted over 20 clinical trials enrolling thousands of patients worldwide to evaluate the efficacy and safety of cariprazine for patients with a broad range of mental health conditions.
Bipolar disorder is a mental disorder that causes periods of depression and abnormally-elevated mood. Bipolar I is characterised by more severe mania, whereas the mania experienced by bipolar II sufferers is less extreme.
Gedeon Richter research director Dr István Greiner said: “Today’s positive results provide further support for the therapeutic value of cariprazine, one of our flagship products. We are encouraged by the findings, which mark a major step forward in making this promising treatment option available for patients suffering from bipolar depression.”
